Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Response of Children With Atopic Dermatitis (Eczema) to Eucrisa

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04023084
Recruitment Status : Not yet recruiting
First Posted : July 17, 2019
Last Update Posted : July 17, 2019
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Anna Fishbein, MD, Ann & Robert H Lurie Children's Hospital of Chicago

Brief Summary:
The purpose of this study is to develop biomarkers to predict what medication is best for each child with atopic dermatitis (eczema). Participants will come in to Lurie Children's Allergy of Dermatology clinic for a skin examination and complete surveys. They will apply Eucrisa medication to their skin for 28 days before returning for a second and final skin examination and complete surveys. During these skin exams, tape will be placed on the skin and removed to collect skin cell samples. Photos will also be taken of the skin where tape was placed. There is an optional blood draw.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Eczema Drug: Crisaborole Phase 4

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Intervention Model Description: children diagnosed with AD and aged 5-17 years old will receive intervention
Masking: None (Open Label)
Primary Purpose: Other
Official Title: PDE4A Expression as a Biomarker of Responsiveness to Eucrisa
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
Drug Information available for: Crisaborole

Arm Intervention/treatment
Experimental: Atopic Dermatitis Group
Receive crisaborole intervention
Drug: Crisaborole
Crisaborole 2% topical ointment applied twice daily to affected area(s) for 28 days
Other Name: Eucrisa




Primary Outcome Measures :
  1. Changes in expression levels of biomarkers in responder versus non responder groups [ Time Frame: Baseline (Day 1) and Day 28 ]
    The baseline mean expression levels of biomarkers extracted from tape strips (TH2 (IL13, IL4R, CCL26), TH17/22 (IL36G), itch (ENKUR), epidermal genes (FLG, LOR and S100A9) and PDE4A will be compared in clinical "responder" versus "non-responder" groups. Groups will be defined by the primary clinical outcome of disease severity improvement by clinician assessment. Clinicians will assess disease severity by Investigator's Static Global Assessment (ISGA) and Eczema Area and Severity Index (EASI) score.


Secondary Outcome Measures :
  1. Changes in Quality of life (anxiety, depressive symptoms, fatigue, mobility, pain interference, peer relationships) as assessed by PROMIS Pediatric Profile 25 and Correlation of changes with clinical responsiveness and biomarker PDE4A expression levels [ Time Frame: Baseline (Day 1) and Day 28 ]
    Changes in quality of life will be measured by comparing standardized PROMIS T-scores for each domain at Day 28 with baseline. The PROMIS Pediatric Profile 25 is a 25-item questionnaire and assesses anxiety, depressive symptoms, fatigue, mobility, pain interference, and peer relationships. Each item has five response options. The HealthMeasures Scoring Service will be used to calculate T-scores for each domain. A T-score of 50 is the average for the United States general population with a standard deviation of 10. A higher T-score represents more of the concept being measured. Responsiveness will be determined by comparing clinician-assessed disease severity by ISGA and EASI scores at baseline and Day 28.

  2. Changes in Quality of life (symptoms and feelings, leisure, school or holidays, personal relationships, sleep, treatment) as assessed by CDLQI and Correlation of Quality of life changes with clinical responsiveness and biomarker PDE4A expression levels [ Time Frame: Baseline (Day 1) and Day 28 ]
    Changes in quality of life will be measured by comparing CDLQI scores at Day 28 with baseline. The CDLQI is a 10-item questionnaire assessing symptoms and feelings, leisure, school or holidays, personal relationships, sleep, and treatment. Scores range from 0 to 30 and are calculated by summing the scores of each question. The higher the score, the more impaired quality of life. Responsiveness will be determined by comparing ISGA and EASI scores at baseline and Day 28.

  3. Correlation of TEWL with clinical responsiveness and biomarker PDE4A expression levels [ Time Frame: Baseline (Day 1) and Day 28 ]
    Diffusion of water through the skin is measured using the AquaFlux instrument. Responsiveness will be determined by comparing ISGA and EASI scores at baseline and Day 28.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • AD diagnosis by dermatologist or allergist based on Hanifin and Rajka criteria
  • 5% or more treatable body surface area involvement
  • baseline Investigator's Static Assessment (ISGA) score of mild (2) or moderate (3)
  • patient on stable regimens (consistent use 14 days before day 1 of enrollment) of inhaled corticosteroids and antihistamines
  • must have lesional skin in the antecubital fossa

Exclusion Criteria:

  • use of topical corticosteroid, calcineurin inhibitor, or PDE4 inhibitor within 14 days of enrollment
  • significant active infection
  • any previous use of biologic therapy
  • no pruritus at baseline visit, or other pruritic condition
  • washing/moisturizer use 24 hours prior to tape strip biomarker collection at site
  • uncontrolled asthma, uncontrolled allergic rhinitis, or other sleep disturbing condition

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04023084


Contacts
Layout table for location contacts
Contact: Jennifer Lor 312-227-6010 jenlor@luriechildrens.org

Locations
Layout table for location information
United States, Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago Not yet recruiting
Chicago, Illinois, United States, 60611
Contact: Jennifer Lor    312-227-6010    jenlor@luriechildrens.org   
Principal Investigator: Anna Fishbein, MD         
Sponsors and Collaborators
Ann & Robert H Lurie Children's Hospital of Chicago
Pfizer
Investigators
Layout table for investigator information
Principal Investigator: Anna Fishbein, MD Ann & Robert H Lurie Children's Hospital of Chicago

Publications:

Layout table for additonal information
Responsible Party: Anna Fishbein, MD, Attending Physician, Allergy & Immunology, Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier: NCT04023084     History of Changes
Other Study ID Numbers: 2019-2879
First Posted: July 17, 2019    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Data will become available after primary publication is accepted.
Access Criteria: Individual participant data will be publicly available through journal publication.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Anna Fishbein, MD, Ann & Robert H Lurie Children's Hospital of Chicago:
dermatologic agents
surveys
questionnaires
topical therapy

Additional relevant MeSH terms:
Layout table for MeSH terms
Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases